FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats a [...]
QMS Configuration vs. Out-of-the-Box: Real-World Considerations
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry
Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality man [...]
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the [...]
EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]
Food Industry FSVP Violations Revealed in FDA Warning Letters
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen [...]
How to Overcome Quality Management Review Challenges
This is the second installment of a two-part series focusing on the importance [...]
What is a Quality Management Review and Why Do You Need Them?
This is the first installment of a two-part series focusing on the importance of [...]
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
